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GS-9137- A Novel HIV-1 Integrase Inhibitor

Phase 2

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Trials Updated: Jul 29, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment278

FDA Designations

No designations recorded

GS-9137- A Novel HIV-1 Integrase Inhibitor clinical trials

GS-9137- A Novel HIV-1 Integrase Inhibitor · 1 trial · 3 indications

Phase 2 1
NCT00298350Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.HIV
COMPLETED278 Analytics
PHASE2COMPLETED
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GS-9137 - A Novel HIV-1 Integrase InhibitorDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * HIV RNA greater than or equal to 1000 c/mL. * Failed/Failing protease inhibitor based antiretroviral therapy. * Stable antiretroviral therapy for greater than or equal to 30 days prior to screening. * Negative Serum Pregnancy Test. * GFR by Cockcroft Gault greater than or equa...

Countries:United StatesPuerto Rico
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Frequently asked questions about GS-9137- A Novel HIV-1 Integrase Inhibitor

What is GS-9137?

GS-9137 is an investigational small molecule developed by Gilead Sciences, Inc. (ticker: GILD) for the treatment of HIV. It is described as a novel HIV-1 integrase inhibitor and has been studied in a Phase 2 clinical trial. It is not yet approved and remains in clinical development.

What is GS-9137 used for in HIV?

GS-9137 is being developed for the treatment of HIV, including HIV-1 and human immunodeficiency virus infection. It was studied in adults aged 18 years and older, including participants in the United States and Puerto Rico, as part of combination antiretroviral therapy regimens.

Who makes GS-9137?

GS-9137 is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the compound in HIV.

What phase is GS-9137 in?

GS-9137 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is GS-9137 in?

GS-9137 was evaluated in one completed Phase 2 trial, NCT00298350, titled Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART. The trial enrolled 278 participants with HIV, HIV-1, or human immunodeficiency virus infection and was conducted in the United States and Puerto Rico.

Is GS-9137 the same as GS-9137 - A Novel HIV-1 Integrase Inhibitor?

Yes. GS-9137 and GS-9137 - A Novel HIV-1 Integrase Inhibitor refer to the same investigational compound. The longer name is a descriptive title used for the asset, while GS-9137 is the shorter designation used in clinical trial listings and development references.